Review of promotion and advertising materials, including healthcare practitioner, managed care, and direct-to-consumer (DTC) pieces
Review of press materials and medical literature for marketed or pipeline products
Preparing or providing assistance in the preparation of responses to federal and state agencies
Audit of promotional materials and FDA Form 2253 Submissions
Pharmacovigilance (Drug Safety) considerations including revisions to product labeling
Assist in product labeling development
Preparing or providing assistance in the preparation of internal policies and SOPs in the development, review, and dissemination of promotional materials
Compliance Services
Corporate Compliance Program (CCP) assistance with a special focus on development of a CCP infrastructure including drafting policies and procedures, developing training and education programs, assisting with the development of monitoring practices, performing risk assessments, and compliance with various State Compliance Laws
Review of continuing medical education programs and charitable contributions
Review of patient assistance programs
Review of market research programs
Preparation or review of commercial, managed care, market research, personal services and other contracts for compliance with OIG Guidelines
Evaluating and structuring advisory boards and investigator meetings
Training Services
Train marketing and sales personnel on guidelines relating to promotion, continuing medical education, and other educational grants, PhRMA Code and OIG Compliance Guidelines
Promotional Regulatory Affairs new hire orientation
Healthcare practitioner speaker training
Legal Services
Partner with Law Firms on Compliance Investigations, Assessments, or Reviews